Tamjidi Skin Institute

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Tamjidi Skin Institute on August 10, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, maintenance records, lack of documentation, and interview, the laboratory failed to follow their established maintenance policy for monthly oiling of cryostat during twenty-one (21) of 21 months reviewed (timeframe November 2020 to the date of inspection, August 10, 2022). Findings include: 1. Review of the laboratory's policies and procedures revealed a "Quality Control Policies and Documentation" section which stated, "9. The fly wheel and moving components on the cryostat are oiled as recommended by the manufacturer, monthly." 2. Review of the laboratory's cryostat maintenance logs from November 2020 until August 10, 2022 revealed a lack of documentation the the oiling of the laboratory's Avantik QS 11 cryostat from November 2020 until August 10, 2022 (a total of 21 months). The inspector requested to review the documentation of the oiling of the cryostat from November 2020 until August 10, 2022. The laboratory provided no documentation for review. 3. In an exit interview with the Clinical Manager on August 10, 2022 at approximately 10:30 AM, the findings were confirmed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports/Mohs maps, and interview, the laboratory failed to ensure the test report accurately indicated the laboratory name and address where testing was performed for five (5) of 5 randomly selected patient test reports /Mohs maps from November 2020 until the date of the survey on August 10, 2022. Findings include: 1. Review of 5 randomly selected patient test reports/Mohs maps from November 2020 until the date of the survey on August 10, 2022 revealed the 5 selected patient test reports/Mohs maps lacked the name and address of the laboratory where the testing was performed: M20-221, M21-059, M21-245, M22-076 and M22- 131. A total of 5 patient reports/Mohs maps. 2. In an exit interview with the Clinical Manager on August 10, 2022 at approximately 10:30 AM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Tamjidi Skin Institute on October 28, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 09/25/2020 and virtual record review conducted on 10/20/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of procedures, Quality Assurance documents and interviews, the laboratory failed to ensure the Avantik Eosin Working Solution, stored in the laboratory for use, was within the manufacturer's stated expiration dates. Findings include: 1. During a laboratory tour, at approximately 9:00 AM, the surveyor noted a bottle of Avantik Eosin Working Solution (lot number H057-21) in the flammable cabinet with a hand written receive date of 12/27/18 and manufacturer stamped expiration date of 3/6/20. The inspector noted a written "opened" date of 4/21 /2020 with approximately one-third of the solution remaining. No additional bottles of Eosin were observed in the storage cabinet or logged in the reagent log as in use. 2. Review of the laboratory's procedure manual revealed a "Monthly Quality Assurance Checklist" that stated, "All reagents, controls, kits, etc that exceeded their expiration date were discarded." The checklist was completed as "(Y)es" from April 2020 to September 2020. 3. Review of the laboratory's reagent log revealed the Avantik Eosin Working Solution lot H057-21 expiration date 3/6/20 was documented as opened/in use on 4/21/2020. 4. Review of the laboratory's Moth's log revealed one-hundred thirty-four (134) patient Mohs slides were prepared and stained with Hematoxylin and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Eosin stain from 4/22/2020 until 10/26/2020. 5. In an interview with the Clinical Manager at approximately 10:15 AM on 10/28/2020, the above findings were confirmed. -- 2 of 2 --